,,ii #aadth ,,congress #b;d ,session ,s4 #bgde ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #e1 #bjaf ,ms4 ,collins 7for herself1 ,ms4 ,warren1 ,mr4 ,kirk1 ,ms4 ,baldwin1 ,mr4 ,alexander1 and ,mrs4 ,murray7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,public ,health ,service ,act to promote the inclusion of minorities in clinical research1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,advancing ,,nih ,strategic ,planning and ,representation in ,medical ,research ,act4 #b4 ,,nih strategic plan 7a7 ,strategic plan ,section #djb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7 is amended-- 7#a7 in subsection 7b77#e71 by inserting before the semicolon the following3 1 and through the development1 implementation1 and updating of the strategic plan developed under subsection 7m72 and 7#b7 by adding at the end the following3 7m7 ,,nih strategic plan 7#a7 ,in general ,not later than #b years after the date of enactment of the ,advancing ,,nih ,strategic ,planning and ,representation in ,medical ,research ,act1 and once every #f years thereafter1 the ,director of ,,nih1 in consultation with the directors of the national research institutes and national centers1 shall develop and submit to the appropriate committees of ,congress and post on the ,internet website of the ,national ,institutes of ,health1 a #f-year coordinated strategy 7to be known as the ,,nih ,strategic ,plan7 to provide direction to the biomedical research investments made by the ,national ,institutes of ,health1 to facilitate collaboration across the institutes and centers1 to leverage scientific opportunity1 and to advance biomedicine4 7#b7 ,requirements ,the strategy under paragraph 7#a7 shall-- 7,a7 identify strategic research priorities and objectives across biomedical research1 including-- 7i7 an assessment of the state of biomedical and behavioral research1 including areas of opportunity with respect to basic1 clinical1 and translational research2 7ii7 priorities and objectives to advance the treatment1 cure1 and prevention of health conditions2 7iii7 emerging scientific opportunities1 rising public health challenges1 and scientific knowledge gaps2 and 7iv7 the identification of near-1 mid-1 and long-term scientific needs2 7,b7 consider1 in carrying out subparagraph 7,a7-- 7i7 disease burden in the ,united ,states2 7ii7 rare diseases and conditions2 7iii7 biological1 social1 and other determinants of health that contribute to health disparities2 and 7iv7 other factors the ,director of ,,nih determines appropriate2 7,c7 include multi-institute priorities1 including coordination of research among institutes and centers2 7,d7 include strategic priorities for funding research through the ,common ,fund1 in accordance with section #djb;,a7c77#a77;,c72 7,e7 address the agency's proposed and ongoing activities related to training and the biomedical workforce2 and 7,f7 describe opportunities for collaboration with other agencies and departments1 as appropriate4 7#c7 ,use of plans ,strategic plans developed and updated by the national research institutes and national centers of the ,national ,institutes of ,health shall be prepared regularly and in such a manner that such plans will be informed by the strategic plans developed and updated under this subsection4 4 7b7 ,conforming amendment ,section #djb;,a7c77#a77;,c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb;a7c77#a77;,c77 is amended by striking ,not later than ,june #a1 #bjjg1 and every #b years thereafter1 and inserting ,as part of the ,,nih ,strategic ,plan required under section #djb7m714 #c4 ,collaboration to enhance diversity in clinical research ,section #djb7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;b77 is amended-- 7#a7 by amending paragraph 7#d7 to read as follows3 7#d7 shall assemble accurate data to be used to assess research priorities1 including-- 7,a7 information to better evaluate scientific opportunity1 public health burdens1 and progress in reducing health disparities2 and 7,b7 data on study populations of clinical research1 funded by or conducted at each national research institute and national center1 which-- 7i7 specifies the inclusion of-- 7,i7 women2 7,,ii7 members of minority groups2 7,,iii7 relevant age categories2 and 7,,iv7 other demographic variables determined to be necessary by the ,director of ,,nih2 7ii7 is disaggregated by research area1 condition1 and disease categories2 and 7iii7 is to be made publicly available on the ,internet website of the ,national ,institutes of ,health2 2 and 7#b7 in paragraph 7#h7-- 7,a7 in subparagraph 7,a71 by striking and at the end2 and 7,b7 by adding at the end the following3 7,c7 foster collaboration between clinical research projects funded by the respective national research institutes and national centers that-- 7i7 conduct research involving human subjects2 and 7ii7 collect similar data2 and 7,d7 encourage the collaboration described in subparagraph 7,c7 to-- 7i7 allow for an increase in the number of subjects studied2 and 7ii7 utilize diverse study populations1 with special consideration to biological1 social1 and other determinants of health that contribute to health disparities2 4 #d4 ,promoting inclusion in clinical research 7a7 ,strategic plan ,section #dib;,b7a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;a-#b7;a77 is amended by adding at the end the following3 7#c7 ,strategic planning 7,a7 ,in general ,the directors of the national institutes and national centers shall consult at least once annually with the ,director of the ,national ,institute on ,minority ,health and ,health ,disparities and the ,director of the ,office of ,research on ,women's ,health regarding objectives of the national institutes and national centers to ensure that future activities by such institutes and centers take into account women and minorities and are focused on reducing health disparities4 7,b7 ,strategic plans ,any strategic plan issued by a national institute or national center shall include details on the objectives described in subparagraph 7,a74 4 7b7 ,clarification of requirements ,section #dib;,b7c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;a-#b7;c77 is amended-- 7#a7 by striking ,in the case and inserting the following3 7#a7 ,in general ,in the case 2 and 7#b7 by adding at the end the following3 7#b7 ,reporting requirements ,for any new and competing project of clinical research subject to the requirements under this section that receives a grant award #a year after the date of enactment of the ,advancing ,,nih ,strategic ,planning and ,representation in ,medical ,research ,act1 or any date thereafter1 for which a valid analysis is provided under paragraph 7#a7-- 7,a7 and which is an applicable clinical trial as defined in section #djb7;j71 the entity conducting such clinical research shall submit the results of such valid analysis to the clinical trial registry data bank expanded under section #djb7;j77#c71 and the ,director of ,,nih shall1 as appropriate1 consider whether such entity has complied with the reporting requirement described in this subparagraph in awarding any future grant to such entity1 including pursuant to section #djb7;j77#e77;,a77ii7 when applicable2 and 7,b7 the ,director of ,,nih shall encourage the reporting of the results of such valid analysis described in paragraph 7#a7 through any additional means determined appropriate by the ,director4 4 7c7 ,reporting ,section #dib;,b7f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;a-#b7;f77 is amended-- 7#a7 by striking biennial each place such term appears and inserting triennial in each such place2 7#b7 by striking ,the advisory council and inserting the following3 7#a7 ,in general ,the advisory council 2 and 7#c7 by adding at the end the following3 7#b7 ,contents ,each triennial report prepared by an advisory council of each national research institute as described in paragraph 7#a7 shall include each of the following3 7,a7 ,the number of women included as subjects1 and the proportion of subjects that are women1 in any project of clinical research conducted during the applicable reporting period1 disaggregated by categories of research area1 condition1 or disease1 and accounting for single-sex studies4 7,b7 ,the number of members of minority groups included as subjects1 and the proportion of subjects that are members of minority groups1 in any project of clinical research conducted during the applicable reporting period1 disaggregated by categories of research area1 condition1 or disease and accounting for single-race and single-ethnicity studies4 7,c7 ,for the applicable reporting period1 the number of projects of clinical research that include women and members of minority groups and that-- 7i7 have been completed during such reporting period2 and 7ii7 are being carried out during such reporting period and have not been completed4 7,d7 ,the number of studies completed during the applicable reporting period for which reporting has been submitted in accordance with subsection 7c77#b77;,a74 4 7d7 ,coordination ,section #dhf7;c77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhg;d7c77#b77 is amended by striking designees and inserting senior-level staff designees4 #e4 ,improving research related to sexual and gender minority populations 7a7 ,in general ,part ,a of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bha et seq47 is amended by adding at the end the following3 #djd,m4 ,research related to sexual and gender minority populations ,the ,director of ,,nih shall1 as appropriate1 encourage efforts to improve research related to the health of sexual and gender minority populations1 including by-- 7#a7 facilitating increased participation of sexual and gender minority populations in clinical research supported by the ,national ,institutes of ,health1 and reporting on such participation1 as applicable2 7#b7 facilitating the development of valid and reliable methods for research relevant to sexual and gender minority populations2 and 7#c7 addressing methodological challenges4 4 7b7 ,reporting 7#a7 ,in general ,the ,secretary1 in collaboration with the ,director of the ,national ,institutes of ,health1 shall as appropriate-- 7,a7 continue to support research for the development of appropriate measures related to reporting health information about sexual and gender minority populations2 and 7,b7 not later than #b years after the date of enactment of this ,act1 disseminate and make public such measures4 7#b7 ,national ,academy of ,medicine recommendations ,in developing the measures described in paragraph 7#a77;,a71 the ,secretary shall take into account recommendations made by the ,national ,academy of ,medicine4 #f4 ,improving coordination related to minority health and health disparities ,section #dfdz-#c of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhet7 is amended-- 7#a7 by redesignating subsection 7h71 relating to interagency coordination1 that follows subsection 7j7 as subsection 7k72 and 7#b7 in subsection 7k7 7as so redesignated7-- 7,a7 in the heading1 by striking ,interagency and inserting ,intra-,,nih2 7,b7 by striking as the primary ,federal officials and inserting as the primary ,federal official2 7,c7 by inserting a comma after review2 7,d7 by striking ,institutes and ,centers of the ,national ,institutes of ,health and inserting national research institutes and national centers2 and 7,e7 by adding at the end the following3 ,the ,director of the ,institute may foster partnerships between the national research institutes and national centers and may encourage the funding of collaborative research projects to achieve the goals of the ,national ,institutes of ,health that are related to minority health and health disparities44 #g4 ,enhancing the rigor and reproducibility of scientific research 7a7 ,establishment ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,national ,institutes of ,health1 shall convene a working group under the ,advisory ,committee to the ,director of the ,national ,institutes of ,health1 appointed under section #bbb of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bag;a71 to develop and issue recommendations for a formal policy1 which may incorporate or be informed by relevant existing and ongoing activities1 to enhance rigor and reproducibility of scientific research funded by the ,national ,institutes of ,health4 7b7 ,considerations ,in developing and issuing the recommendations under subsection 7a71 the working group established under such subsection shall consider1 as appropriate-- 7#a7 preclinical experiment design1 including analysis of sex as a biological variable2 7#b7 clinical experiment design1 including-- 7,a7 the diversity of populations studied for clinical research1 with respect to biological1 social1 and other determinants of health that contribute to health disparities2 7,b7 the circumstances under which summary information regarding biological1 social1 and other factors that contribute to health disparities should be reported2 and 7,c7 the circumstances under which clinical studies1 including clinical trials1 should conduct an analysis of the data collected during the study on the basis of biological1 social1 and other factors that contribute to health disparities2 7#c7 applicable levels of rigor in statistical methods1 methodology1 and analysis2 7#d7 data and information sharing in accordance with applicable privacy laws and regulations2 and 7#e7 any other matter determined relevant by the working group4 7c7 ,policies ,not later than #ah months after the date of enactment of this ,act1 the ,director of the ,national ,institutes of ,health shall consider the recommendations developed by the working group under subsection 7a7 and develop or update policies as appropriate4 7d7 ,report ,not later than #b years after the date of enactment of this ,act1 the ,director of the ,national ,institutes of ,health1 acting through the working group established under subsection 7a71 shall issue a report to the ,secretary of ,health and ,human ,services1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives regarding recommendations developed under such subsection and any subsequent policy changes implemented1 to enhance rigor and reproducibility in scientific research funded by the ,national ,institutes of ,health4 7e7 ,confidentiality ,nothing in this section shall authorize the ,secretary of ,health and ,human ,services to disclose any information that is a trade secret1 or other privileged or confidential information1 described in section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 #h4 ,task ,force on research specific to pregnant women and lactating women 7a7 ,task force on research specific to pregnant women and lactating women 7#a7 ,establishment ,not later than #ij days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall establish a task force1 in accordance with the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app471 to be known as the ,task ,force on ,research ,specific to ,pregnant ,women and ,lactating ,women 7in this section referred to as the ,task ,force74 7#b7 ,duties ,the ,task ,force shall provide advice and guidance to the ,secretary regarding ,federal activities related to identifying and addressing gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women1 including the development of such therapies and the collaboration on and coordination of such activities4 7#c7 ,membership 7,a7 ,federal members ,the ,task ,force shall be composed of each of the following ,federal members1 or the designee of such member3 7i7 ,the ,director of the ,centers for ,disease ,control and ,prevention4 7ii7 ,the ,director of the ,national ,institutes of ,health1 the ,director of the ,eunice ,kennedy ,shriver ,national ,institute of ,child ,health and ,human ,development1 and the directors of such other appropriate national research institutes4 7iii7 ,the ,commissioner of ,food and ,drugs4 7iv7 ,the ,director of the ,office on ,women's ,health4 7v7 ,the ,director of the ,national ,vaccine ,program ,office4 7vi7 ,the head of any other research-related agency or department not described in clauses 7i7 through 7v7 that the ,secretary determines appropriate1 which may include the ,department of ,veterans ,affairs and the ,department of ,defense4 7,b7 ,non-,federal members ,the ,task ,force shall be composed of each of the following non-,federal members1 including-- 7i7 representatives from relevant medical societies with subject matter expertise on pregnant women1 lactating women1 or children2 7ii7 nonprofit organizations with expertise related to the health of women and children2 7iii7 relevant industry representatives2 and 7iv7 other representatives1 as appropriate4 7,c7 ,limitations ,the non-,federal members described in subparagraph 7,b7 shall-- 7i7 compose not more than one-half1 and not less than one-third1 of the total membership of the ,task ,force2 and 7ii7 be appointed by the ,secretary4 7#d7 ,termination 7,a7 ,in general ,subject to subparagraph 7,b71 the ,task ,force shall terminate on the date that is #b years after the date on which the ,task ,force is established under paragraph 7#a74 7,b7 ,extension ,the ,secretary may extend the operation of the ,task ,force for one additional #b-year period following the #b-year period described in subparagraph 7,a71 if the ,secretary determines that the extension is appropriate for carrying out the purpose of this section4 7#e7 ,meetings ,the ,task ,force shall meet not less than #b times each year and shall convene public meetings1 as appropriate1 to fulfill its duties under paragraph 7#b74 7#f7 ,task force report to ,congress ,not later than #ah months after the date on which the ,task ,force is established under paragraph 7#a71 the ,task ,force shall prepare and submit to the ,secretary1 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report that includes each of the following3 7,a7 ,a plan to identify and address gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women1 including the development of such therapies4 7,b7 ,ethical issues surrounding the inclusion of pregnant women and lactating women in clinical research4 7,c7 ,effective communication strategies with health care providers and the public on information relevant to pregnant women and lactating women4 7,d7 ,identification of ,federal activities1 including-- 7i7 the state of research on pregnancy and lactation2 7ii7 recommendations for the coordination of1 and collaboration on research related to pregnant women and lactating women2 7iii7 dissemination of research findings and information relevant to pregnant women and lactating women to providers and the public2 and 7iv7 existing ,federal efforts and programs to improve the scientific understanding of the health impacts on pregnant women1 lactating women and1 related birth and pediatric outcomes1 including with respect to pharmacokinetics1 pharmacodynamics1 and toxicities4 7,e7 ,recommendations to improve the development of safe and effective therapies for pregnant women and lactating women4 7b7 ,confidentiality ,nothing in this section shall authorize the ,secretary of ,health and ,human ,services to disclose any information that is a trade secret1 or other privileged or confidential information1 described in section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 7c7 ,updating protections for pregnant women and lactating women in research 7#a7 ,in general ,not later than #b years after the date of enactment of this ,act1 the ,secretary1 considering any recommendations of the ,task ,force available at such time and in consultation with the heads of relevant agencies of the ,department of ,health and ,human ,services1 shall1 as appropriate1 update regulations and guidance1 as applicable1 regarding the inclusion of pregnant women and lactating women in clinical research4 7#b7 ,criteria for excluding pregnant or lactating women ,in updating any regulations or guidance described in paragraph 7#a71 the ,secretary shall consider any appropriate criteria to be used by institutional review boards and individuals reviewing grant proposals for excluding pregnant women or lactating women as a study population requiring additional protections from participating in human subject research4 #i4 ,women and minorities in research 7a7 ,basic research 7#a7 ,developing policies ,not later than #b years after the date of enactment of this ,act1 the ,director of the ,national ,institutes of ,health 7referred to in this section as the ,director of ,,nih71 taking into consideration the findings of the working group established under section #g1 shall develop policies for projects of basic research funded by ,national ,institutes of ,health to assess-- 7,a7 relevant biological variables including sex1 as appropriate2 and 7,b7 how differences between male and female cells1 tissues1 or animals may be examined and analyzed4 7#b7 ,revising policies ,the ,director of ,,nih may update or revise the policies developed under paragraph 7#a7 as appropriate4 7#c7 ,consultation and outreach ,in developing1 updating1 or revising the policies under this section1 the ,director of ,,nih-- 7,a7 shall consult with-- 7i7 the ,office of ,research on ,women's ,health2 7ii7 the ,office of ,laboratory ,animal ,welfare2 and 7iii7 appropriate members of the scientific and academic communities2 and 7,b7 shall conduct outreach to solicit feedback from members of the scientific and academic communities on the influence of sex as a variable in basic research1 including feedback on when it is appropriate for projects of basic research involving cells1 tissues1 or animals to include both male and female cells1 tissues1 or animals4 7#d7 ,additional requirements ,the ,director of ,,nih shall-- 7,a7 ensure that projects of basic research funded by the ,national ,institutes of ,health are conducted in accordance with the policies developed1 updated1 or revised under this section1 as applicable2 and 7,b7 encourage that the results of such research1 when published or reported1 be disaggregated as appropriate with respect to the analysis of any sex differences4 7b7 ,clinical research 7#a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,director of ,,nih1 in consultation with the ,director of the ,office of ,research on ,women's ,health and the ,director of the ,national ,institute on ,minority ,health and ,health ,disparities1 shall update the guidelines established under section #dib;,b7d7 of ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;a-#b7;d77 in accordance with paragraph 7#b74 7#b7 ,requirements ,the updated guidelines described in paragraph 7#a7 shall-- 7,a7 reflect the science regarding sex differences2 7,b7 improve adherence to the requirements under section #dib;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;a-#b71 including the reporting requirements under subsection 7f7 of such section2 and 7,c7 clarify the circumstances under which studies should be designed to support the conduct of analyses to detect significant differences in the intervention effect due to demographic factors related to section #dib;,b of the ,public ,health ,service ,act1 including in the absence of prior studies that demonstrate a difference in study outcomes on the basis of such factors and considering the effects of the absence of such analyses on the availability of data related to demographic differences4